FDA 510(k)

RightLance 血液穿刺系统

K号: K222034 · 2022-09-07

申请人Beijing Ruicheng Medical Supplies Co., Ltd.

决定日期2022-09-07

产品代码QRL

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决定实质等同

器械摘要

RightLance Blood Lancing System is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Ruicheng Medical Supplies Co., Ltd.. It received FDA 510(k) clearance on 2022-09-07 under 510(k) number K222034. The device is classified under product code QRL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the RightLance Blood Lancing System?

RightLance Blood Lancing System is a medical device that received FDA 510(k) clearance on 2022-09-07. The listed applicant is Beijing Ruicheng Medical Supplies Co., Ltd.. The 510(k) number is K222034.

When did RightLance Blood Lancing System receive FDA 510(k) clearance?

RightLance Blood Lancing System received FDA 510(k) clearance on 2022-09-07, under 510(k) number K222034.

Who is the listed applicant for RightLance Blood Lancing System?

The FDA 510(k) record lists Beijing Ruicheng Medical Supplies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RightLance Blood Lancing System?

The FDA product code for RightLance Blood Lancing System is QRL.

列明Beijing Ruicheng Medical Supplies Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K222408一次性安全注射针

相关器械（代码：QRL）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262135刺针Tianjin Huahong Technology Co., Ltd.K262211lancetTianjin Huahong Technology Co., Ltd.K260122穿刺器（PressGo, LDE3, LDE3AST, LDE5, EasyStep）SteriLance Medical (Suzhou), Inc.K253706刺针 (HH-XV-T)Tianjin Huahong Technology Co., Ltd.K250813MICROLET®NEXT 2 刺针装置Ascensia Diabetes Care U.S., Inc.K243306lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); 刺针 (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T)Tianjin Huahong Technology Co., Ltd.

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